The present invention generally relates to diagnostic testing devices and more specifically relates to a device for containing a fluid sample, for example a urine specimen, and conducting diagnostic testing of the contained fluid sample.
Assay testing of bodily fluids, for example blood, urine and salivary fluid, is well known but serious disadvantages are presented by conventional devices which expose a technician to physical contact with the fluid. For example a common test performed by health care workers involves testing a maternity patient for signs of gestational diabetes. The patient collects a sample of urine in a sterile cup and closes the cup with a lid. With gloved hands, the health care worker removes the lid and manually immerses an end of a diagnostic test strip into the urine sample. The worker then manually removes the test strip from the sample, and may perform analysis of any color change or other visible indicia on the test strip. Although the risk of contamination between the patient and the health care worker may be small in this situation, there is always some risk involved when the health care worker is exposed to an open container of bodily fluid. Further, there is also a risk of cross contamination between different patients when multiple tests are being performed. Because the test strip is handled separately from the container, there is a potential risk of test results being misidentified between patients.
Other diagnostic test procedures, for example immunoassay testing procedures involve using a pipette or other device to manually extract a small amount of a fluid sample from an open collection container, thus also presenting a risk of contamination or exposure to disease.
Conventional devices have been developed to overcome these and other disadvantages of such open-cup fluid testing procedures. In U.S. Pat. No. 5,501,837 to Sayles, a specimen testing system is disclosed which utilizes a cup having a cover lid. Within the cover lid are contained one or more reagent membrane strips used for conducting chromatographic immunoassay testing of a fluid deposited in the cup when the cup is inverted. Although offering an advantage over open-cup test procedures, the Sayles invention, and others similar thereto, are not significantly cost effective to manufacture as they require rotatable components, assembling of reagent strips within a lid assembly. Furthermore, the method of use of the Sayles invention requires the cup to be inverted, thus increasing a risk of the fluid leaking therefrom, for example if the cover lid has not been sufficiently secured.
There is still a need for an economical, easy to manufacture device which reduces or substantially eliminates the risks associated with diagnostic testing of bodily fluids.
The present invention provides a cost-effective, easy to manufacture and highly reliable device for collecting and testing bodily fluids, such as urine for example. The device is designed to substantially overcome the disadvantages of prior devices and procedures, including reducing risk of specimen contamination and injury to health care workers.
A diagnostic device, in accordance with the present invention, for collecting and testing a fluid specimen, generally comprises a cup or other container suitable for holding a fluid specimen, particularly a bodily fluid specimen, for example urine, and test means, sealed to the cup, for indicating a presence of at least one specific component of the fluid specimen.
More particularly, the test means includes a reagent strip, for example a conventional reagent strip, including a portion for displaying visible indicia of test results. An adhesive member overlying the reagent strip is provided for sealing the strip to an inner surface of the cup. The reagent strip may be positioned on an inner surface of the cup, preferably with the test results portion thereof facing the inner surface of the cup and being visible through the outer surface of the cup. For example, at least a portion of the cup is clear or sufficiently transparent to enable one to see test results on the reagent strip. The adhesive member may be an adhesive plastic label that provides a fluid tight seal around a periphery of the reagent strip against the inner surface of the cup. The fluid sample collected in the cup is prevented from contacting the reagent strip, with the exception of the sample introduction end or portion of the test strip, which is exposed to the fluid sample by means of a cut-out portion defined in the adhesive label. More particularly, a die cut aperture in the adhesive member provides means for introducing the fluid specimen contained in the cup and onto the sample introduction end, or other appropriate portion of the the reagent strip to cause the fluid sample to migrate along the reagent strip by capillary action. The sample introduction end may include a sample pad for absorbing the fluid specimen and saturating the sample introduction end of the reagent strip and a conjugate pad.
In one feature of the present invention, a small filter may be provided on the sample introduction end of the reagent strip, for example a filter paper disposed over the adhesive label aperture, in order to pre-filter the fluid sample prior to its entry into the sample pad.
As the seal provided by the adhesive label about the reagent strip is substantially fluid tight, preferably means are provided for venting air from the reagent strip as the fluid sample migrates along the reagent strip. For example, in one advantageous embodiment of the invention, the means for venting comprises a second aperture in the adhesive member, the second aperture being covered with a hydrophobic material adapted to prevent fluid flow into the reagent strip while enabling air flow out of the reagent strip.
It is to be appreciated that in one broad embodiment of the invention, the container is not considered as a part of the invention, and the invention may comprise the test means as being adapted to be sealed or adhered to any suitable cup or container.
In another feature of the invention, the test device may further comprise a substantially opaque member providing means for masking or concealing the test means from view through the outer surface of the cup means, while also revealing the test results portion of the reagent strip. For example, the opaque member may comprise an adhesive label adhered to the outer surface of the container and including a cut-out portion or clear window exposing the test results through the outer surface of the cup. The opaque label may also include information inscribed thereon, for example adjacent the window, for enabling identification of test results on the reagent strip.